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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04518540
Date of registration: 05/08/2020
Prospective Registration: Yes
Primary sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Public title: Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
Scientific title: Randomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral Sclerosis
Date of first enrolment: September 1, 2020
Target sample size: 150
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04518540
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
China
Contacts
Name:     Zhi-Ying Wu, MD&PhD
Address: 
Telephone: +86-571-87783569
Email: zhiyingwu@zju.edu.cn
Affiliation: 
Name:     zhiying wu, Ph.D
Address: 
Telephone: 13646715353
Email: zhiyingwu@zju.edu.cn
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age range from 20 to 75 (including 20 and 75 years old), regardless of ethnic group or
gender;

2. The subjects should meet the diagnostic criteria for ALS by El Escorial revised
criteria: "Definite ALS", "Probable ALS" and "Probable, laboratory-supported ALS".

3. ALS Functional Rating Scale-Revised (ALSFRS-R 12 items) each item score =2 points;

4. The onset (the symptoms of limbs weakness, muscle atrophy or bulbar involvement ) of
the disease is less than 2 years

5. Baseline breath function: Forced Vital Capacity=70% .

6. Disease Progression Rate FS=(48- ALSFRS-R at "time of diagnosis")/duration from onset
to diagnosis (month), progression rate FS=1;

Exclusion Criteria:

1. Combined with one of cerebrovascular disease, spinal cord disease, spinal muscular
atrophy, juvenile myoatrophy of distal upper extremity, multifocal motor neuropathy,
Kennedy disease, epilepsy, etc;

2. Severe renal insufficiency: creatinine clearance rate <30 mL/min (Cockcroft-Gault
formula, urea nitrogen and (or) blood creatinine> 1.5 times the upper limit of normal,
or other known severe renal insufficiency diseases;

3. Severe liver damage: ALT, AST> 3 times the upper limit of normal, or other known liver
diseases such as acute and chronic hepatitis, cirrhosis, etc.;

4. Obvious tachycardia or bradycardia; patients with acute myocardial infarction or
interventional therapy in the past 6 months (patients with grade III-IV according to
NYHA classification);

5. Combined with malignant tumor, blood, digestion or other serious diseases;

6. Female patients during pregnancy and lactation;

7. Participated in other clinical trials within 30 days before randomization, or are
participating in other clinical trials;



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Intervention(s)
Drug: control group
Drug: lipoic acid group
Primary Outcome(s)
change of Amyotrophic lateral sclerosis Function Rate Scale-Revised (ALSFRS-R) [Time Frame: change from baseline to 11th week& 21th week]
Secondary Outcome(s)
change of Motor Neuron Disease Electromyography [Time Frame: change from baseline EMG to 21th week]
change of Muscle strength scale [Time Frame: change from baseline to 11th week& 21th week]
change of Pulmonary Forced Vital Capacity (PFVC) [Time Frame: change from baseline to 11th week& 21th week]
change of Rasch Overall ALS Disability Scale (ROADS) [Time Frame: change from baseline to 11th week& 21th week]
change of Upper motor neuron scale (UMNS) [Time Frame: change from baseline to 11th week& 21th week]
Secondary ID(s)
2020-375
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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